Eriksson Lars B, Gordh Torsten, Karlsten Rolf, Thor Andreas, Tegelberg Åke
Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.
Centre for Clinical Research, Uppsala University, Falun, Sweden.
Br J Pain. 2024 Jun 20:20494637241262509. doi: 10.1177/20494637241262509.
To study patient safety in third molar surgery, where two different doses of S-ketamine were administered for pain relief and compared to a placebo (saline). The primary focus was capillary oxygen saturation of the blood (SpO) and secondarily, alterations in respiratory rate, blood pressure, pulse or adverse events.
One hundred and sixty-eight subjects were included in a randomised, placebo-controlled, double-blind trial. The two subanaesthetic study drugs were low-dose S-ketamine (0.125 mg/kg) and high-dose S-ketamine (0.25 mg/kg). Every patient was sedated with midazolam prior to infusion of the investigational drug. The teeth were surgically removed according to a routine clinical procedure, under local anaesthesia.
Primary end-point for the safety aspects was capillary oxygen saturation (SpO) after administration of the investigational drug was finished. A significant difference was found between the placebo and the high-dose group at that point ( = .021), with a decrease of saturation in the high-dose group. The lowest saturation and the number of registrations of SpO <90% did not show any difference between groups. Oxygen supplementation was given in circa 40% of the cases with no differences between the intervention groups. No other significant differences between groups regarding saturation or respiratory rate were noted.
In this study, it was safe to use adjunct preoperative single-dose intravenous S-ketamine 0.25 mg/kg body weight for pain relief, in midazolam-sedated patients receiving third molar surgery. There were no serious adverse events or symptoms of overdose nor any clinically relevant effects on circulatory or respiratory parameters.
研究在第三磨牙手术中患者的安全性，在该手术中给予两种不同剂量的S-氯胺酮用于缓解疼痛，并与安慰剂（生理盐水）进行比较。主要关注的是血液中的毛细血管血氧饱和度（SpO），其次是呼吸频率、血压、脉搏的变化或不良事件。
168名受试者纳入一项随机、安慰剂对照、双盲试验。两种亚麻醉剂量的研究药物分别为低剂量S-氯胺酮（0.125mg/kg）和高剂量S-氯胺酮（0.25mg/kg）。在输注研究药物前，每位患者均用咪达唑仑镇静。在局部麻醉下，按照常规临床程序手术拔除牙齿。
安全性方面的主要终点是研究药物输注结束后的毛细血管血氧饱和度（SpO）。此时，安慰剂组和高剂量组之间存在显著差异（P = 0.021），高剂量组饱和度降低。最低饱和度以及SpO<90%的记录次数在各组之间未显示出任何差异。约40%的病例给予了氧气补充，各干预组之间无差异。在饱和度或呼吸频率方面，各组之间未发现其他显著差异。
在本研究中，对于接受第三磨牙手术且用咪达唑仑镇静的患者，术前单次静脉注射0.25mg/kg体重的S-氯胺酮辅助缓解疼痛是安全的。没有严重不良事件或过量症状，对循环或呼吸参数也没有任何临床相关影响。
